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EP1656961B1 - Immunotoleranter Stent mit Oberflächen-Mikrostruktur - Google Patents

Immunotoleranter Stent mit Oberflächen-Mikrostruktur Download PDF

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Publication number
EP1656961B1
EP1656961B1 EP05024079.5A EP05024079A EP1656961B1 EP 1656961 B1 EP1656961 B1 EP 1656961B1 EP 05024079 A EP05024079 A EP 05024079A EP 1656961 B1 EP1656961 B1 EP 1656961B1
Authority
EP
European Patent Office
Prior art keywords
stent
immuno
microstructures
suppressing drug
range
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP05024079.5A
Other languages
English (en)
French (fr)
Other versions
EP1656961A1 (de
Inventor
Eckhard Dr. Alt
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
Original Assignee
Inflow Dynamics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/847,626 external-priority patent/US6613083B2/en
Application filed by Inflow Dynamics Inc filed Critical Inflow Dynamics Inc
Priority to EP05024079.5A priority Critical patent/EP1656961B1/de
Publication of EP1656961A1 publication Critical patent/EP1656961A1/de
Application granted granted Critical
Publication of EP1656961B1 publication Critical patent/EP1656961B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/0076—Chemical modification of the substrate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus

Definitions

  • the invention refers to a method of making a stent and a stent producible with said method.
  • Stents are widely used to support a lumen in the human body, especially the lumen of a coronary artery.
  • a wide range of solutions have been proposed including a modification of the stent surface by iridiumoxide or the coating of the stent surface with biodegradable or non-biodegradable coatings. It has been proposed to provide the stent surface with a coating of an immuno suppressing drug, namely "Tacrolimus", which prevents or at least reduces the immuno-response by a modification of the immuno-response of the body. These drugs are otherwise used to suppress the rejection of transplants in the human body. In addition, recent research has shown, that a rough stent surface may be advantageous to prevent restenosis. However, precise predictions and results could not be achieved as yet.
  • WO 00/10623 discloses a stent with a surface pattern comprising a plurality of depressions with an average diameter of about 30 - 65 micrometers to achieve an organised growth pattern of infiltrating cells in order to avoid immuno-reactions of the body leading to restenosis.
  • the solution is, to minimize the surface recognition of the stent as an implanted foreign body creating a stent surface, which is more immuno tolerant than a smooth or generally rough surface. It has shown, that the stent restenosis primarily is a foreign body recognition with concomitant inflammatory reaction against the implanted foreign body, very similar to the rejection of a transplanted organ with a foreign body surface to the body. This reaction primarily is brought forward by T-Lymphocytes. These Lymphocytes attack anything which is determined to be foreign and a release of Cytokines is affected following this recognition.
  • the aim of this invention is to allow the proliferation of smooth muscle cells to the same degree as they normally would proliferate, but suppress the continuous overshooting proliferation that goes beyond the wound healing.
  • This overshooting proliferation is responsible for the restenosis and is based on an inflammatory response toward the foreign body which is recognized by the T-cell system.
  • an immuno suppressive drug such as Sirolimus or Tacrolimus helps to overcome the very weak inflammatory response toward such an implanted foreign body, which is not only due to the surface recognition, but also to the mechanical trauma which is brought forward by the implantation of the stent.
  • the application of the immuno drug can be effected either by dipping the stent in a solution of the drug.
  • a solution of the drug for example, 40 mg Tacrolimus are dissolved in 6 ml of Chloroform or Ethylacetate and on the stent surface soaked by adhesion forces and by capillary forces the drug into the surface coating.
  • the stent is taken out of the solution and the solvent evaporates following the high pressure of the dissolved chloroform into the ambient atmosphere rapidly. The consequence is, that dependent on the initial concentration small traces of the drug are bound to the surface and soaked into the network, the grooves and the capillaries of the rough surface structure of the stent.
  • the surface modification of the stent serves two purposes:
  • biodegradable or non-biodegradable carrier can be done as well.
  • drugs had been described previously and are consisting of either biodegradable such as polylactic acid or non-biodegrable or non-erodable polymers such as polyurethane, polyvinylacetate or other.
  • Fig. 1 shows a part of a stent 10 in form of a small tube 20 preferably made of a niob-zirconium alloy which has two open ends (one is shown at 24) and a lot of openings 26 in the wall of the tube 20, so that the stent may be crimped on an angioplasty balloon(not shown) and deployed by the balloon on a treatment site for example in a coronary artery from its shown first small diameter to a second greater diameter so that the outer surface of the stent is in contact with the inner wall surface of the artery.
  • Many designs of the stent are possible and well known in the state of the art; for the invention the configuration of the stent is not relevant.
  • the outer surface of the stent 10 is modified and provided with small protrusions or microstructures 28 as shown in Figs. 2 and 3 for a small region D depicted in Fig. 1 .
  • These microstructures have a lateral extension d in the range of 0.5 to 5 micrometers, preferably in the range of 1 to 3 micrometers.
  • the spacing e between adjacent microstructures is in the same range of 0.5 to 5 micrometers, preferably in the range of 1 to 3 micrometers, as schematically shown in Fig. 3 .
  • the height h of the microstructures between the peak of a microstructure and the valley adjacent to a next microstructure may have a lower value and lie in the range of 0.5 to 2 micrometers.
  • the microstructures 28. may be a coating 30 of a ceramic-like material such as iridiumoxide, which may be deposited on the surface of the surface of the stent by means of plasma or chemical vapour deposition or the like.
  • the microstructures 28 may have the form of microspheres or parts thereof; the surface of the microstructures may not be smooth and be provided with grooves or furrows 32 depending on the manufacturing process.
  • the stent is then dipped into a solution of an immuno suppressing drug, for example "Tacrolimus” or “Sirolimus", and a solvent such as chloroform, so that the solution covers the surface of the stent, partially by capillary forces in the region of the grooves 32 .
  • an immuno suppressing drug for example "Tacrolimus” or “Sirolimus”
  • a solvent such as chloroform

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Materials For Medical Uses (AREA)

Claims (19)

  1. Ein Verfahren zur Herstellung eines Stents zur Implantierung in ein Lumen des menschlichen Körpers, umfassend:
    Bereitstellen eines Stents, der versehen ist mit einer rauen äußeren Oberfläche, dadurch gekennzeichnet dass die Oberfläche des Stents Mikrostrukturen umfasst, die laterale Abmessungen (d) in dem Bereich von 0,5 bis 5 Mikrometern aufweisen und voneinander durch Abstände (e) getrennt sind,
    wodurch die Erkennung des Stents als ein implantierter Fremdkörper verringert ist; und
    Aufbringen eines immunsupprimierenden Arzneistoffs auf die raue äußere Oberfläche, wobei der immunsupprimierende Arzneistoff eine innere Oberfläche des Lumens behandelt und dessen Immunreaktion verhindert.
  2. Verfahren nach Anspruch 1, wobei der Aufbringungsschritt das Eintauchen des Stents in eine Lösung umfassend den immunsupprimierenden Arzneistoff und ein Lösungsmittel umfasst.
  3. Verfahren nach Anspruch 2, wobei die Lösung auf die Oberfläche des Stents durch eine kapillare Kraft dieser Oberfläche aufgebracht wird.
  4. Verfahren nach Anspruch 3, wobei der immunsupprimierende Arzneistoff an der Oberfläche des Stents der kapillaren Kraft folgend ohne Verwendung eines Trägers anhaftet.
  5. Verfahren nach Anspruch 4, wobei der immunsupprimierende Arzneistoff in das Netzwerk, die Vertiefungen und die Kapillarien der Mikrostrukturen der Stentoberfläche eindringt.
  6. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei die laterale Abmessungen (d) der Mikrostrukturen im Berrich von 1 bis 3 Mikrometer liegen.
  7. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei die Abstände (e) zwischen benachbarten Mikrostrukturen in dem Bereich von 0.5 bis 5 Mikrometern liegen.
  8. Verfahren nach Anspruch 7, wobei die Abstände (e) zwischen benachbarten Mikrostrukturen in dem Bereich von 1 bis 3 Mikrometern liegen.
  9. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei die Oberflächenstruktur des Stents inert ist und keine toxischen Substanzen freisetzt.
  10. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei die Oberflächenstruktur des Stents eine Oberflächenladung in dem Bereich von 3 x 10-2 bis 5 x 10-2 N/m (30-50 dynes/cm (g x cm x s-2/cm)) aufweist.
  11. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei der immunsupprimierende Arzneistoff in der Lage ist, ein Immunreaktion oder - antwort durch Interaktion mit den T-Zellen des menschlichen Körpers zu unterdrücken.
  12. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei der immunsupprimierende Arzneistoff Sirolimus ist.
  13. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei der immunsupprimierende Arzneistoff Tacrolimus ist.
  14. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei die durch die Mikrostrukturen modifizierte Oberfläche aus Iridiumoxid hergestellt ist.
  15. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei die durch die Mikrostrukturen modifizierte Oberfläche aus Nioboxid hergestellt ist.
  16. Verfahren nach irgendeinem der vorstehenden Ansprüche, wobei die durch die Mikrostrukturen modifizierte Oberfläche aus Titannitrat hergestellt ist.
  17. Verfahren nach Anspruch 13, wobei das Lösungsmittel Chloroform ist.
  18. Verfahren nach Anspruch 17, wobei das Chloroform von der Oberfläche des Stents verdampft wird.
  19. Ein Stent zur Implantierung in ein Lumen des menschlichen Körpers, wobei der Stent durch das Verfahren nach irgendeinem der Ansprüche 1 bis 18 herstellbar ist.
EP05024079.5A 2001-05-02 2001-12-31 Immunotoleranter Stent mit Oberflächen-Mikrostruktur Expired - Lifetime EP1656961B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05024079.5A EP1656961B1 (de) 2001-05-02 2001-12-31 Immunotoleranter Stent mit Oberflächen-Mikrostruktur

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US09/847,626 US6613083B2 (en) 2001-05-02 2001-05-02 Stent device and method
EP01124528A EP1254674B2 (de) 2001-05-02 2001-10-12 Endovaskulärer Stent mit Takrolimus enthaltender Beschichtung
EP05024079.5A EP1656961B1 (de) 2001-05-02 2001-12-31 Immunotoleranter Stent mit Oberflächen-Mikrostruktur
EP20010131051 EP1254673B1 (de) 2001-05-02 2001-12-31 Immunotoleranter Stent mit Oberflächen-Mikrostruktur

Related Parent Applications (1)

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EP20010131051 Division EP1254673B1 (de) 2001-05-02 2001-12-31 Immunotoleranter Stent mit Oberflächen-Mikrostruktur

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EP1656961A1 EP1656961A1 (de) 2006-05-17
EP1656961B1 true EP1656961B1 (de) 2015-08-05

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EP20010131051 Expired - Lifetime EP1254673B1 (de) 2001-05-02 2001-12-31 Immunotoleranter Stent mit Oberflächen-Mikrostruktur

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9284409B2 (en) 2007-07-19 2016-03-15 Boston Scientific Scimed, Inc. Endoprosthesis having a non-fouling surface

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Publication number Publication date
EP1656961A1 (de) 2006-05-17
EP1254673B1 (de) 2005-11-09
EP1254673A1 (de) 2002-11-06

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